This clinical trial explores the effectiveness of transcutaneous spinal cord stimulation (tSCS), a non-invasive technique, in facilitating spinal circuitry adaptation in individuals with spinal cord injury (SCI). While epidural spinal cord stimulation (eSCS) has shown functional benefits, its application is limited by the side effects associated with implanted electrodes. tSCS, which shares a similar mechanism but does not require surgery, has yet to be extensively studied in large human trials. The study aims to: Determine optimal tSCS parameters for non-invasive spinal stimulation. Investigate the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training. Examine the long-term clinical outcomes of combining tSCS with ankle movement training in individuals with incomplete SCI. The trial will include both healthy participants and individuals with complete and incomplete SCI, using the soleus post-activation depression (PAD) model to evaluate spinal circuitry adaptation. The results will provide insights into spinal re-adaptation and potentially introduce a novel, non-invasive approach for SCI rehabilitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The subjects will undergo 20 minutes transcutaneous spinal cord stimulation (tSCS).
The subjects will undergo 30 minutes of machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS) at a time
The subjects will undergo machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS). Each session will last for 30 minutes, conducted three times per week, over a period of four weeks.
Chang Gung University
Taoyuan, Taiwan
RECRUITINGLatency and amplitude of the H-reflex
The H-reflex will be elicited through electrical stimulation of the tibial nerve (or sciatic nerve) using electromyography (EMG) to record the resulting muscle response.
Time frame: Baseline, 4 weeks
Latency, amplitude, and duration of the M-wave
The M-wave will be elicited by direct electrical stimulation of the motor nerve (e.g., tibial nerve) and recorded using electromyography (EMG) from the target muscle (e.g., soleus muscle).
Time frame: Baseline, 4 weeks
Level of Post-Activation Depression (PAD) of the H-reflex
The H-reflex will be elicited by electrical stimulation of the tibial nerve (or other motor nerves), and PAD will be assessed by measuring the reduction in H-reflex amplitude following a series of repetitive stimuli. The amplitude of the H-reflex after repeated stimulation will be compared to the baseline single stimulus.
Time frame: Baseline, 4 weeks
Latency and amplitude of the Posterior Root Muscle (PRM) reflex
The PRM reflex will be elicited by stimulating the posterior roots of the spinal cord (typically via electrical stimulation of the dorsal roots), and the resulting muscle activity will be recorded using electromyography (EMG)
Time frame: Baseline, 4 weeks
Muscle spasticity levels as assessed by the Modified Ashworth Scale (MAS).
Muscle spasticity will be evaluated using the MAS, which grades the resistance encountered during passive movement of the affected limb (e.g., arm or leg). The scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).
Time frame: Baseline, 4 weeks
Muscle Tone (Frequency, Hz)
This parameter measures the natural oscillation frequency of the muscle in response. It reflects the muscle's state of tension or readiness.
Time frame: Baseline, 4 weeks
Elasticity (Dynamic Stiffness, N/m)
Elasticity, measured in Newtons per meter, reflects the muscle's ability to return to its original shape after being deformed by the impulse
Time frame: Baseline, 4 weeks
Stiffness (Decay, ms)
This parameter quantifies the rate at which the muscle returns to its initial state after the impulse, indicating the muscle's stiffness
Time frame: Baseline, 4 weeks
Mechanical Stress (Creep, s) and Relaxation (S)
These parameters measure the time it takes for muscle tissue to adapt to a sustained force (creep) and the time it takes for the muscle to return to a relaxed state after removing the force (relaxation).
Time frame: Baseline, 4 weeks
Foot pressure distribution and peak pressure.
Foot pressure will be measured using pressure sensors during ankle movement
Time frame: Measured continuously during CPM
The score of 10-meter walking test (10MWT)
To measure walking speed over a short distance as a quantitative index of walking ability.
Time frame: Baseline, 4 weeks.
Ankle Joint Range of Motion (ROM)
These movements measure the ability to move the foot up towards the shin (dorsiflexion) and down away from the body (plantarflexion). Typical instruments used include a universal goniometer or an inclinometer. The patient is typically seated or lying down with the knee extended for accurate measurement.
Time frame: Baseline, 4 weeks
Knee Joint ROM
These are the primary movements of the knee, involving bending (flexion) and straightening (extension) of the leg. Measurements are taken with the patient seated or lying down. A goniometer is placed on the lateral aspect of the knee to record the angle of maximum bend and extension.
Time frame: Baseline, 4 weeks
Overall the Patient Reported Impact of Spasticity Measure(PRISM) Score
An aggregated score derived from all the individual items within the questionnaire, providing a comprehensive measure of the impact of spasticity on the patient's quality of life
Time frame: Baseline, 4 weeks
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